Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.
FDA Recall Z-1663-2008 · Posted 2008-09-19
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Recalling FirmAscent Healthcare Solutions, Inc.
Recall StatusTerminated
Product CodeNLF
Date Initiated2008-03-11
Date Terminated2012-06-29
Product Quantity1752 of 1752 (data indicates 1776 dist - some devices were returned and redistributed)
Reason for Recall
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Firm Action
A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at [email protected].
Root Cause
Process control
Distribution Pattern
Class II Recall - Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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